Validation of a Composite Medical Device Using a Blood Biomarker-based Algorithm and MDQ for the Diagnosis of Bipolar Disorder

The goal of this interventional clinical trial is to assess the diagnostic performance of a composite diagnostic medical devise based on blood-based in vitro diagnostic device and Mood Disorder Questionnaire (MDQ) in identifying bipolar disorder among adult patients presenting with a current major depressive episode in primary care. The study will compare the results of the medical device diagnostic test to those of standardized psychiatric clinical evaluation, to evaluate its sensitivity, specificity, and overall clinical utility. The main research questions are : * Can the investigational medical device accurately distinguish bipolar disorder from unipolar depression ? * How does its diagnostic accuracy compare with validated psychiatric questionnaires commonly used in clinical practice ? Participants will : * Provide a blood sample for biomarker analysis using the investigational diagnostic device. * Complete a few validated psychiatric assessment tools (e.g., MDQ, MINI). * Share sociodemographic and clinical data relevant to psychiatric evaluation.

NCT Number	NCT07031817
Lead Sponsor	University Hospital, Montpellier Collaborators: CH Béziers, Centre Hospitalier Universitaire de Nīmes, Assistance Publique Hopitaux De Marseille, University Hospital, Toulouse, Nantes University Hospital, USSAP Carcassonne, Ajaccio Hospital Center, CH TOULON, CH Thuir, CH Montauban, Centre de Ressources Biologiques de Montpellier, Federation Regionale de Recherche en Psychiatrie et Sante Mentale Occitanie
Conditions	Bipolar Disorder (BD), Major Depressive Episode (MDE), Primary Care, Major Depression
Enrollment	623 participants
Start Date	2025-09-30
Primary Completion	2027-10-01 (estimated)
Study Completion	2028-07-01 (estimated)
Updated on ClinicalTrials.gov	2025-10-07